Cleared Traditional

K151491 - Falck Medical Multifunction Tonometer

K151491 is the FDA 510(k) clearance for Falck Medical Multifunction Tonometer by Falck Medical, Inc.. It is a Class 2 Ophthalmic device (product code HKY) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K151491 · Falck Medical, Inc. · Ophthalmic device
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Jan 2016
Decision
226d
Days
Class 2
Risk

K151491 is an FDA 510(k) clearance for the Falck Medical Multifunction Tonometer, FAT1. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Falck Medical, Inc. (Mystic, US). The FDA issued a Cleared decision on January 15, 2016 after a review of 226 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Falck Medical, Inc. devices

Submission Details

510(k) Number K151491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2015
Decision Date January 15, 2016
Days to Decision 226 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 110d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKY Tonometer, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKY Tonometer, Manual

All 17
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K151491.
Applanation tonometer AT-2
K182491 · Takagi Seiko Co., Ltd. · Dec 2018
AT 030
K180839 · Carl Zeiss Meditec, AG · Jun 2018
CATS Tonometer Prism
K173904 · Cats Tonometer, LLC · Mar 2018
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · Medtronic Xomed, Inc. · Mar 2006
PROVIEW EYE PRESSURE MONITOR
K011199 · Bausch & Lomb, Inc. · Jul 2001
JAKOBI SURG. INSTRUMENTS #6 50
K834187 · Imm Enterprises , Ltd. · Mar 1984